Regulatory Affairs Associate in UK

Location: Leverstock Green
Salary: £35,000 per year
Recruiter: WhatJobs
Job Hours: Unknown
I am working in partnership with a leading healthcare manufacturer, who are a dynamic, and innovative company with a large portfolio of products. They specialise in the development of new products, using their unique technology platform. Due to growth in the business, they are looking for a Regulatory Affairs Associate to join the Regulatory Affairs Team. The role will involve providing regulatory support to a number of regulatory projects, related to products and/or market entry. The role will include registrations, file updates, label changes, application of new or updated regulations (MDR, UDI, BPR, EPR etc.). The Role: * Planning, preparing and filing of global regulatory submissions for marketing authorisations, variations, supplements, amendments, promotional materials, labelling and other regulatory submissions as required by the business. * Act as internal regulatory consultant for labelling/packaging, artwork for commercial portfolio across the regions. * Carry out registrations, file updates, label changes, application of new or updated regulations (MDR, UDI, BPR, EPR etc.) * Work with other Project Managers within the business to link regs requirements into other areas such as R&D, Quality and Marketing. * Prioritise activities of each project individually, projects within the regs group and those across the wider business. * Communicate project status within the Regs team and across the business. * Coordination with external, regulatory stakeholders. The Candidate: * Ideally an honours degree, in a scientific or equivalent subject. * Good background in Regulatory Affairs, ideally with experience within the Medical Devices, Pharmaceutical or Cosmetic industry. * Self-motivated with the ability to deliver a high standard of work within agreed deadlines. * Excellent interpersonal and organisational skills. Must be able to work well within a team and display strong problem-solving skills. * Must work efficiently and be self-disciplined. Able to work well under pressure and to be able to identify the need to prioritise when required

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